Reported Jun 11, 2025 · Ongoing
Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM)…
Dexcom, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dexcom, Inc. · 6340 Sequence Dr · San Diego, CA · 92121-4356
Is this the product you have?
- Dexcom G7 iOS Application
- RefSW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system
- Lot codes and dates
- Software version 2.7.0/
- UDI00386270001863
- Amount recalled
- 61,355 users
Where it was sold
Why it was recalled
A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show this stale EGV. If the user is unaware that the EGVs are not being updated and that glucose alerts will not trigger, there is potential for the missed detection of a hyperglycemic or hypoglycemic event or a treatment decision made based off incorrect data. There is no impact to transmitter communication with concurrently connected displays. A concurrently connected receiver, Apple Watch, and/or insulin pump will continue to receive EGVs directly from the transmitter when the app is in the problematic state. There is no impact to Automated Insulin Dosing (AID) therapy as the AID system continues to receive EGVs directly from the transmitter.
This product could cause temporary or reversible health problems — stop using it.
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